Project Manager, Clinical Trials

The Project Manager, Clinical Trials is responsible to develop detailed project plans for Oncology Investigator Initiated Trials (IITs). This includes but not limited to overseeing and driving the clinical research trials from concept to final deliverables in a timely and effective manner. The project manager will manage, collaborate, and communicate with teams of investigators, co-writers and expert contributors always emphasizing clarity in message delivery and the highest standards of integrity. In collaboration with clinical investigators, the Project Mgr, Clinical Trials will be responsible for developing clinical protocol(s), manual of procedures, and other study documents required for conduct of clinical trials. In addition, the Project Mgr, Clinical Trials will be responsible for the oversight and ongoing conduct of all Oncology IITs being conducted at the John Theurer Cancer Center.

Responsibilities

A day in the life of a Project Manager, Clinical Trials at Hackensack Meridian Health includes:

• Manages multiple investigator-initiated clinical trials.
• Oversees reports and assists with statistical analysis.
• Assists study team in the preparation of all audits performed by various governing agencies, study monitors, and other compliance efforts.
• Oversees and drives projects from concept to final deliverables in form of publications, clinical study reports, final reports to funding agency, etc.
• Acts as a liaison between the investigator and funding agency, and third-party contractors for study-specific issues.
• Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors, Regulatory Specialists Contract Research Organizations, and employees of Hackensack University Medical Center.
• Coordinates preparation of and assists with the development of protocols, informed consent forms, monitoring and validation plans.
• Oversees submission of IND Application to FDA as needed.
• Designs case report forms and liaises with data analyst for database development.
• Coordinates study manuals of procedures for site coordinators, pharmacists, and laboratory technicians.
• Develops and presents training materials for investigators, coordinators, pharmacists, laboratory technicians, and monitors.
• Verifies trials are progressing according to quality standards and federal regulations.
• Guides on-site monitors by providing training, identifying issues to address on site; assist with resolution of issues and tracking corrective action plans (if CRO)
• Arranges, prepares for, and documents meetings between clinical researchers, sponsors, and coordinating center members.
• Builds research infrastructure to support multi-center clinical trials.
• Performs project management for ad hoc JTCC projects as needed.
• Adheres to the standards identified in the Medical Center's Organizational Competencies.

Qualifications

Education, Knowledge, Skills and Abilities Required:

• Bachelor's degree in a scientific or medical discipline with at least 3 years of experience in clinical research.
• Experience in clinical protocol and trial document development.
• Solid knowledge of Good Clinical Practice guidelines and Protection of Human Subjects regulations.
• Expertise in MS Word and Excel, including the ability to solve technical problems with documents and templates; proficiency with Access and a variety of database applications; experience with EndNote and Adobe Acrobat.

Licenses And Certifications Preferred

• Society of Clinical Research Associates Certification.